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NCT06517810 · ClinicalTrials.gov registry record
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
A clinical trial of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, sponsored by SeaStar Medical.
- Recruiting
- Registry status
- 300
- Enrollment target
- 15
- Study locations
NCT06517810: Recruiting study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, sponsored by SeaStar Medical.
NCT06517810 is a study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis that is actively recruiting participants, run by SeaStar Medical. The registered enrollment target is 300 participants, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06517810, a study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, is actively recruiting participants, sponsored by SeaStar Medical.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 15
- Study locations
Study Summary
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
Primary Outcome
New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner
Conditions Studied
Interventions
- DEVICE QUELIMMUNE (SCD-PED)
Study Locations (15)
Texas
- Children's Medical Center Dallas - Dallas
- Cook Children's Hospital - Fort Worth
- Texas Children's Hospital - Houston
California
- Lucile Packard Children's Hospital Stanford - Palo Alto
- UCSF Benioff Children's - San Francisco
Georgia
- Children's Hospital of Atlanta - Arthur M. Blank - Atlanta
- Children's Hospital of Atlanta - Scottish Rite - Atlanta
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cleveland Clinic Children's Hospital - Cleveland
Alabama
- Children's of Alabama - Birmingham
Colorado
- HealthONE HCA Rocky Mountain Children's Hospital - Denver
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Michigan
- CS Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2026-05 |
What NCT06517810 shows while recruiting
NCT06517810 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention - of which QUELIMMUNE (SCD-PED) is the first listed.
NCT06517810 lists 15 locations in 10 states (Texas, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT06517810 about?
NCT06517810 is a clinical study titled "QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry". QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients...
What is the current status of trial NCT06517810?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-07-19. Estimated completion is 2026-05.
What conditions does trial NCT06517810 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Acute Kidney Injury Due to Sepsis.
What interventions are being tested in trial NCT06517810?
The interventions under investigation include: QUELIMMUNE (SCD-PED) (DEVICE).
Who is sponsoring clinical trial NCT06517810?
This trial is sponsored by SeaStar Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06517810 being conducted?
This trial has 15 study locations across Alabama, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06517810's enrollment target sits among peer trials
300 25th of 74 higher than 48 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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